{
 "drug": "Sterile Water Irrigant",
 "asOf": "2026-08-25",
 "status": "in-shortage",
 "since": "04/28/2023",
 "dayN": 1215,
 "cat": "Gastroenterology",
 "companies": [
  "Baxter Healthcare",
  "Otsuka ICU Medical LLC",
  "B. Braun Medical Inc."
 ],
 "reasons": [
  "Demand increase for the drug",
  "Discontinuation of the manufacture of the drug"
 ],
 "records": [
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0338-0004-03",
   "generic_name": "Sterile Water Irrigant",
   "contact_info": "888-229-0001",
   "availability": "Limited Availability",
   "related_info": "Estimated recovery: August 2026",
   "openfda": {
    "application_number": [
     "NDA017428"
    ],
    "brand_name": [
     "STERILE WATER"
    ],
    "generic_name": [
     "WATER"
    ],
    "manufacturer_name": [
     "Baxter Healthcare Corporation"
    ],
    "product_ndc": [
     "0338-0004",
     "0338-0003"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "IRRIGATION"
    ],
    "substance_name": [
     "WATER"
    ],
    "rxcui": [
     "150985"
    ],
    "spl_id": [
     "97390588-b679-4caa-b7f3-3d2e11074d0e"
    ],
    "spl_set_id": [
     "ef3e79c5-3f58-4b36-a296-64b7d9a651c1"
    ],
    "package_ndc": [
     "0338-0003-44",
     "0338-0003-46",
     "0338-0003-47",
     "0338-0004-02",
     "0338-0004-03",
     "0338-0004-04",
     "0338-0004-05"
    ],
    "unii": [
     "059QF0KO0R"
    ]
   },
   "update_date": "08/17/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-03)",
   "company_name": "Baxter Healthcare",
   "shortage_reason": "Demand increase for the drug",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0338-0004-04",
   "generic_name": "Sterile Water Irrigant",
   "contact_info": "888-229-0001",
   "availability": "Limited Availability",
   "related_info": "Estimated recovery: September 2026",
   "openfda": {
    "application_number": [
     "NDA017428"
    ],
    "brand_name": [
     "STERILE WATER"
    ],
    "generic_name": [
     "WATER"
    ],
    "manufacturer_name": [
     "Baxter Healthcare Corporation"
    ],
    "product_ndc": [
     "0338-0004",
     "0338-0003"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "IRRIGATION"
    ],
    "substance_name": [
     "WATER"
    ],
    "rxcui": [
     "150985"
    ],
    "spl_id": [
     "97390588-b679-4caa-b7f3-3d2e11074d0e"
    ],
    "spl_set_id": [
     "ef3e79c5-3f58-4b36-a296-64b7d9a651c1"
    ],
    "package_ndc": [
     "0338-0003-44",
     "0338-0003-46",
     "0338-0003-47",
     "0338-0004-02",
     "0338-0004-03",
     "0338-0004-04",
     "0338-0004-05"
    ],
    "unii": [
     "059QF0KO0R"
    ]
   },
   "update_date": "08/17/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-04)",
   "company_name": "Baxter Healthcare",
   "shortage_reason": "Demand increase for the drug",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0990-7139-36",
   "generic_name": "Sterile Water Irrigant",
   "related_info_link": "https://www.fda.gov/media/182619/download?attachment",
   "contact_info": "1-866-829-9025 or ProductAvailability@icumed.com",
   "availability": "Unavailable",
   "related_info": "Product temporarily unavailable. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions regarding this product, please contact ICU Medical.",
   "update_date": "08/17/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-7139-36)",
   "company_name": "Otsuka ICU Medical LLC",
   "shortage_reason": "Discontinuation of the manufacture of the drug",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0990-6139-03",
   "generic_name": "Sterile Water Irrigant",
   "related_info_link": "https://www.fda.gov/media/182619/download?attachment",
   "contact_info": "1-866-829-9025 or ProductAvailability@icumed.com",
   "availability": "Unavailable",
   "related_info": "Product temporarily unavailable. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions regarding this product, please contact ICU Medical.",
   "update_date": "08/17/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-6139-03)",
   "company_name": "Otsuka ICU Medical LLC",
   "shortage_reason": "Discontinuation of the manufacture of the drug",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0264-2101-10",
   "generic_name": "Sterile Water Irrigant",
   "contact_info": "800-227-2862",
   "availability": "Available",
   "openfda": {
    "application_number": [
     "NDA016734"
    ],
    "brand_name": [
     "STERILE WATER"
    ],
    "generic_name": [
     "WATER"
    ],
    "manufacturer_name": [
     "B. Braun Medical Inc."
    ],
    "product_ndc": [
     "0264-2101"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "IRRIGATION"
    ],
    "substance_name": [
     "WATER"
    ],
    "rxcui": [
     "150985"
    ],
    "spl_id": [
     "969bdf41-6565-42fb-8ac1-8661a928cc22"
    ],
    "spl_set_id": [
     "f4284eb6-e553-46d4-90d8-efc80a90a480"
    ],
    "package_ndc": [
     "0264-2101-00",
     "0264-2101-10",
     "0264-2101-50",
     "0264-2101-70"
    ],
    "unii": [
     "059QF0KO0R"
    ]
   },
   "update_date": "08/07/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-10)",
   "company_name": "B. Braun Medical Inc.",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0990-7139-09",
   "generic_name": "Sterile Water Irrigant",
   "related_info_link": "https://www.fda.gov/media/182619/download?attachment",
   "contact_info": "1-866-829-9025 or ProductAvailability@icumed.com",
   "availability": "Unavailable",
   "related_info": "Product temporarily unavailable. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions regarding this product, please contact ICU Medical.",
   "update_date": "08/17/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-7139-09)",
   "company_name": "Otsuka ICU Medical LLC",
   "shortage_reason": "Discontinuation of the manufacture of the drug",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0338-0004-02",
   "generic_name": "Sterile Water Irrigant",
   "contact_info": "888-229-0001",
   "availability": "Available",
   "openfda": {
    "application_number": [
     "NDA017428"
    ],
    "brand_name": [
     "STERILE WATER"
    ],
    "generic_name": [
     "WATER"
    ],
    "manufacturer_name": [
     "Baxter Healthcare Corporation"
    ],
    "product_ndc": [
     "0338-0004",
     "0338-0003"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "IRRIGATION"
    ],
    "substance_name": [
     "WATER"
    ],
    "rxcui": [
     "150985"
    ],
    "spl_id": [
     "97390588-b679-4caa-b7f3-3d2e11074d0e"
    ],
    "spl_set_id": [
     "ef3e79c5-3f58-4b36-a296-64b7d9a651c1"
    ],
    "package_ndc": [
     "0338-0003-44",
     "0338-0003-46",
     "0338-0003-47",
     "0338-0004-02",
     "0338-0004-03",
     "0338-0004-04",
     "0338-0004-05"
    ],
    "unii": [
     "059QF0KO0R"
    ]
   },
   "update_date": "08/17/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-02)",
   "company_name": "Baxter Healthcare",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0264-2101-00",
   "generic_name": "Sterile Water Irrigant",
   "contact_info": "800-227-2862",
   "availability": "Available",
   "openfda": {
    "application_number": [
     "NDA016734"
    ],
    "brand_name": [
     "STERILE WATER"
    ],
    "generic_name": [
     "WATER"
    ],
    "manufacturer_name": [
     "B. Braun Medical Inc."
    ],
    "product_ndc": [
     "0264-2101"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "IRRIGATION"
    ],
    "substance_name": [
     "WATER"
    ],
    "rxcui": [
     "150985"
    ],
    "spl_id": [
     "969bdf41-6565-42fb-8ac1-8661a928cc22"
    ],
    "spl_set_id": [
     "f4284eb6-e553-46d4-90d8-efc80a90a480"
    ],
    "package_ndc": [
     "0264-2101-00",
     "0264-2101-10",
     "0264-2101-50",
     "0264-2101-70"
    ],
    "unii": [
     "059QF0KO0R"
    ]
   },
   "update_date": "08/07/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-00)",
   "company_name": "B. Braun Medical Inc.",
   "status": "Current"
  },
  {
   "update_type": "Reverified",
   "initial_posting_date": "04/28/2023",
   "package_ndc": "0990-6139-22",
   "generic_name": "Sterile Water Irrigant",
   "related_info_link": "https://www.fda.gov/media/182619/download?attachment",
   "contact_info": "1-866-829-9025 or ProductAvailability@icumed.com",
   "availability": "Unavailable",
   "related_info": "Product temporarily unavailable. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions regarding this product, please contact ICU Medical.",
   "update_date": "08/17/2026",
   "therapeutic_category": [
    "Gastroenterology",
    "Other",
    "Pediatric"
   ],
   "dosage_form": "Irrigant",
   "presentation": "Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-6139-22)",
   "company_name": "Otsuka ICU Medical LLC",
   "shortage_reason": "Discontinuation of the manufacture of the drug",
   "status": "Current"
  }
 ]
}